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PMCs as a Treatment of Children With HSPM Using the HT

Preformed Metal Crowns (PMCs) as a Treatment of Children With Hypomineralised Second Primary Molars (HSPM) Using the Hall Technique (HT)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04265183
Enrollment
15
Registered
2020-02-11
Start date
2018-11-09
Completion date
2020-07-31
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypomineralization of Enamel

Keywords

preformed metal crowns, Hall technique

Brief summary

Hypomineralised primary second molars are primary molars with a developmental disorder of the enamel. Preformed metal crowns already have good results for the treatment of caries on primary molars. In this study the aim is to investigate the clinical success and overall survival of preformed metal crowns as a treatment for hypomineralised primary molars. The crowns were placed using the Hall technique which is a simplified way of placing these crowns.

Interventions

OTHERPlacing preformed metal crowns using Hall technique.

Preformed metal crowns (3M™ ESPE™ STAINLESS STEEL CROWNS) were placed after using separation elastics (Dentalastics® separators, DENTAURUM). The crowns were cemented using is a self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement (Ketac™ Cem Plus Luting Cement, 3M™ ESPE™). The technique used to place the crowns was the Hall technique (technique without tooth preparation).

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Months to 144 Months
Healthy volunteers
No

Inclusion criteria

* age 2-12 years * American Society of Anesthesiologists(ASA)-score I: healthy patient * hypomineralisation grade: 2-6 * caries with an International Caries Detection and Assessment System (ICDAS)- score: 0-3 * limited provoked pain complaint

Exclusion criteria

* caries with an ICDAS-score: 4-6 * pulpitis pain complaints * infection (clinical and/or radiographic) * \>1/3 root resorption * allergies to the used materials

Design outcomes

Primary

MeasureTime frameDescription
The clinical success of preformed metal crowns using Hall technique on hypomineralised second primary molars based on clinical acceptable results.1-2 yearThe results are clinical acceptable when there are no clinical signs of infection of the tooth, no caries development or heavy bleeding of the gingiva (after probing).
The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable clinical outcomes.1-2 yearThe outcomes are clinically acceptable when there are no signs of infection (abscess) or caries.
The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable radiographical outcomes.1-2 yearThe outcomes are radiographical acceptable when no signs of infection or interproximal bone loss are seen on the radiographs.

Secondary

MeasureTime frameDescription
The results can be affected by bruxism. Signs of bruxism will not mean failure. We will rate the wear as acceptable or successful. This bruxism will be measured by clinical signs of wear on the crowns.1-2 yearWhen the wear of the crown is limited to minimal loss of metal, it is rated successful. When the wear is going through the full thickness of the crown until the underlying tooth structure, it is rated as acceptable.
The oral hygiene of the patient will be measured using the Simplified Oral Hygiene Index. The minimum value is 0: clean. The maximum value is 3: tooth surface covered with >2/3 soft dental plaque. The higher the score, the worse the outcome.1-2 yearOral hygiene of the patients scored as debris \>1/3 of the crown surface is scored as bad oral hygiene. Bad oral hygiene implies a higher prevalence of (heavy) bleeding of the gingiva after probing. Which has a significant influence on the clinical success of the crowns.

Countries

Belgium

Contacts

Primary ContactDominique Declerck, Prof. Dr.
dominique.declerck@uzleuven.be+3216332307
Backup ContactEmily Mampay
emily.mampay@uzleuven.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026